MARLBOROUGH, Mass., Feb. 2, 2017 /PRNewswire/ -- Hologic, Inc. (Nasdaq: HOLX) today announced the launch of its next-generation NovaSure® ADVANCED global endometrial ablation (GEA) system in the United States. The system has been FDA approved.
The NovaSure system is designed to reduce abnormal uterine bleeding (AUB) by applying radiofrequency energy to the endometrium, gently ablating the lining of the uterus in two minutes or less.1 The NovaSure ADVANCED device offers a slimmer 6 mm diameter designed to improve patient comfort and physician ease-of-use while maintaining the clinical efficacy of the trusted NovaSure system.
The NovaSure ADVANCED device has a smaller sheath size requiring less cervical dilation than the 8 mm NovaSure device, which is the current standard of care. By minimizing the dilation required, physicians can reduce patient discomfort when performing the NovaSure procedure in an office setting.
The updated device is also equipped with an acorn-like shaped cervical seal that creates an increased sealing surface within the cervical canal and provides 13% more "working length" than the previous device.2 Additional enhancements include rounded Smooth Access™ tips to simplify insertion† and a blue handle that serves as a useful reminder for how the device should be inserted.
The NovaSure ADVANCED system launched in Europe, Canada and Australia in 2016.
"I have relied on the NovaSure system for years and it has proven superior to other endometrial ablation modalities, offering a safe, effective and rapid treatment to heavy menstrual bleeding," said Dr. Francis Gardner, Consultant Gynaecologist at the Queen Alexandra Hospital in Portsmouth, England. "The introduction of the NovaSure ADVANCED system is a significant advancement. In addition to providing a more comfortable experience for patients due to the smaller diameter, physicians, like myself, will be able to perform more procedures in office, while maintaining the same efficacy of the trusted NovaSure system."
Abnormal uterine bleeding is a condition that affects one in five women and can be lifestyle-restricting.3 NovaSure endometrial ablation is a one-time procedure that can be performed either in the doctor's office or the operating room. The procedure is safe and effective, dramatically reducing or stopping menstrual bleeding in 90% of women.4 More than 2.5 million women have chosen the NovaSure procedure to treat abnormal uterine bleeding.2
"The next-generation NovaSure ADVANCED system promises the same efficacy and safety profile that physicians have trusted for more than 10 years," said Dr. Edward Evantash, Medical Director, Hologic. "As a part of our ongoing commitment to our customers, we evolved the NovaSure system to provide the enhancements our customers requested to improve physician ease-of-use and ensure an optimal patient experience."
For more information on NovaSure ADVANCED, visit www.novasure.com/ADVANCED.
Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems and surgical products. The Company's core business units focus on diagnostics, breast health, GYN surgical and skeletal health. With a unified suite of technologies and a robust research and development program, Hologic is dedicated to The Science of Sure. For more information on Hologic, visit www.hologic.com.
Hologic, NovaSure, Smooth Access, The Science of Sure, and associated logos are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries. All other trademarks, registered trademarks, and product names are the property of their respective owners.
This news release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic products. There can be no assurance these products will achieve the benefits described herein or that such benefits will be replicated in any particular manner with respect to an individual patient, as the actual effect of the use of the products can only be determined on a case-by-case basis. In addition, there can be no assurance that these products will be commercially successful or achieve any expected level of sales. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements presented herein to reflect any change in expectations or any change in events, conditions or circumstances on which any such data or statements are based.
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- NovaSure Instructions for Use
- Hologic Inc., Data on file, 2016
- Centers for Disease Control and Prevention. Blood disorders in women: heavy menstrual bleeding. http://www.cdc.gov/ncbddd/blooddisorders/women/menorrhagia.html. Accessed September 24, 2015
- Cooper J, Gimpleson R, Laberge P, et al. A randomized, multicenter trial of safety and efficacy of the NovaSure system in the treatment of menorrhagia. J Am Assoc Gynecol Laparosc. 2002;9(4):418-428
† Based on internal bench testing that measured perceived ease of insertion through a simulated cervix of both the 6-mm and 8-mm devices. N=16 surgeon users
SOURCE Hologic, Inc.